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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

Helen Asssistant — Class I MDR by Worldish AB

MD Atlas
Worldish AB

EUDAMED last updated this device on Jan 28, 2026

Helen Asssistant

730000908040helen3T

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Worldish AB
UDI-DI code: 07300009080403
Reference / catalog number: EU-101

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View device family (Basic UDI)

Manufacturer information

Organization name: Worldish AB
SRN: SE-MF-000051584
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Sweden; available across 1 country total.

Placed on the market in Sweden; per-country availability dates not published.

Device identification

Trade name: Helen Asssistant
UDI-DI code: 07300009080403
Basic UDI-DI: 730000908040helen3T
Reference / catalog number: EU-101
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Helen Assistant is an AI-based digital interpretation, translation, and communication tool designed for safe multilingual communication in healthcare settings. It is designed to facilitate clear medical communication between healthcare professionals and patients via speech, visual aids, and text, overcoming communication barriers involving language barriers, medical complexity, and medical terminology in real-time.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)07300009080403

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EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

V92MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

EZRAI730000908040helen3TOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.